Trital DM

Generic Name: dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride
Dosage Form: oral liquid

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Trital™ DM Liquid

Antihistamine/Nasal Decongestant/Cough Suppressant

Alcohol Free • Sugar Free • Dye Free

Trital DM Description

A clear liquid having a grape flavor and odor. Each teaspoonful (5mL.) contains:

Dextromethorphan Hydrobromide, USP 15 mg
Chlorpheniramine Maleate, USP 4 mg
Phenylephrine Hydrochloride, USP 10 mg

INACTIVE INGREDIENTS

Citric Acid, Glycerin, Sodium Benzoate, Sorbitol Solution, Grape Flavor and Purified Water.

Phenylephrine Hydrochloride

C9H13NO2HCl                      M.W. 203.67

Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-.

Chlorpheniramine Maleate

C16H19CIN2C4H4O4                      M.W. 390.86

2-Pyridinepropanamine, γ-(4-chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate.

Dextromethorphan Hydrobromide

C18H25NO • HBr • H2O                      M.W. 370.32

Morphinan, 3-Methoxy-17-methyl-, (9α, 13α, 14α)-, hydrobromide, monohydrate.

INDICATIONS

For the temporary relief of cough due to minor throat and bronchial irritation as may occur with the common cold or with inhaled irritants. Temporarily relieves nasal congestion, runny nose, and sneezing due to the common cold, hay fever, or other upper respiratory allergies.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. May cause drowsiness; alcohol; sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. May cause excitability, especially in children. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, a breathing problem such as emphysema or chronic bronchitis, glaucoma, or difficulty in urination due to enlargement of the prostate gland unless directed by doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough or other symptoms persist for more than one week, without improvement, tend to recur, or are accompanied by fever, rash, or persistent headache, consult a doctor. Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Precautions

Information for Patients

Phenylephrine is banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Drug Interactions

Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

Pregnancy

Category C

Animal reproduction studies have not been conducted with this product. It is not known whether this medication can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Trital™ DM should be given to a pregnant woman only if the potential benefit justifies the possible risk to the fetus.

Pediatric Use

Safety and effectiveness in the pediatric population, under 6, have not been established.

Trital DM Dosage and Administration

Adults and Children 12 years of age or older

One teaspoonful every four hours as needed.

Children 6 to 12 years of age

One-half teaspoonful every four hours as needed. Do not exceed six doses in a 24-hour period. Do not take this product for more than 7 days.

This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

How Supplied

Trital™ DM is a Sugar-Free, Alcohol-Free and Dye-Free liquid supplied in 16 fl. oz. bottles, NDC 51991-131-16.

Store at 25°C (77°F); excursions permitted to 15°-30° C (59°-86°F). See USP Controlled Room Temperature Protect from freezing.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx Only

Manufactured by:
Tri-Med Laboratories, Inc., Somerset, NJ 08873

Distributed by:
Breckenridge Pharmaceutical, Inc.,
Boca Raton, FL 33487

REV. 6/09
ISS. 12/03

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-131-16

TritalDM
Liquid

  • Sugar Free
  • Dye Free
  • Alcohol Free

Description: Each 5ml (one teaspoonful) for oral
administration contains:

Dextromethorphan Hydrobromide, USP 15 mg
Chlorpheniramine Maleate, USP 4 mg
Phenylephrine Hydrochloride, USP 10 mg

INACTIVE INGREDIENTS: Citric Acid, Glycerin,
Sodium Benzoate, Sorbitol Solution, Grape Flavor
and Purified Water.

Do not use if tamper-evident seal is broken or missing.

Rx Only

Net Contents:
16 fl oz (One Pint) 473 mL

Trital DM 
dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-131
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 4 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
sodium benzoate  
citric acid monohydrate  
glycerin  
sorbitol  
water  
Product Characteristics
Color WHITE (Clear) Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-131-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/15/2004 12/31/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
TriMed Laboratories, Inc. 182050567 MANUFACTURE
Revised: 10/2010
 
Breckenridge Pharmaceutical, Inc.



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